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CGMP Issues at Private Label Grooming

[ Price : $8.95]

FDA warns Henderson, NV-based Private Label Grooming about CGMP violations in its production of over-the-counter drugs.

Multiple Violations in Spectra Therapy Inspection

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FDA warns Port Huron, MI-based Spectra Therapy about Quality System, Medical Device Reporting, and Unique Identifier violations in...

Promising Ianalumab Data for Thrombocytopenia: Novartis

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Novartis says its experimental antibody ianalumab, when combined with eltrombopag, significantly extended the time to treatment fa...

Draeger Recalls Ventilator Breathing Filters

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Draeger recalls (Class 1) its SafeStar and TwinStar breathing filters due to a risk of misleading carbon dioxide readings.

Elsa Hallucinations Not A Surprise: AI Expert

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AI expert Brooke Moy says FDA may have felt pressured to move too quickly to implement its Elsa internal AI tool without planning ...

Brinsupri Approved for Non-Cystic Fibrosis Bronchiectasis

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FDA approves an Insmed NDA for Brinsupri (brensocatib) tablets as the first treatment for non-cystic fibrosis bronchiectasis in pa...

Keytruda/Padcev Study in Bladder Cancer Positive: Merck

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Merck announces that the combination of Keytruda (pembrolizumab) and Pfizers Padcev (enfortumab vedotin-ejfv), given before and af...

Get Strategic Intelligence from Device Warnings

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A MedDevice Online column says manufacturers can often avoid an FDA Warning Letter by providing an urgent and accountable full res...

FDA May Nix Pfizer EUA for Covid Jab in Young Kids

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The Guardian reports that the emergency use authorization for Pfizers Covid-19 vaccine for children under five may not be renewed ...